CN107469223A - A kind of hypotube and its sacculus dilating catheter - Google Patents

The present invention relates to medical treatment device technical field, and in particular to a kind of hypotube and its sacculus dilating catheter.Wherein, a kind of hypotube, from near-end to distally forming successively：Pipe section, its cross section are the tubular structure of annulus；Flat tube section, its cross section are the tubular structure of crescent；Supporting section, the supporting section are to extend along the circular arc sheet structure that direction is gradually reduced along the extension of proximate direction and its cross sectional dimensions.Therefore, the technical problem to be solved in the present invention is to overcome foley's tube rigidity and/or flexibility of the prior art can not rounding off, cause distal component that kinking occurs, the defects of causing foley's tube can not smoothly reach lesion locations, so provide it is a kind of with can be with the hypotube of rounding off and the sacculus dilating catheter with the hypotube with distal component.

A kind of hypotube and its sacculus dilating catheter

Technical field

The present invention relates to medical treatment device technical field, and in particular to a kind of hypotube and its sacculus dilating catheter.

Background technology

Coronary heart disease is the number one killer in angiocardiopathy, and there is nearly 20,000,000 patients with coronary heart disease in China, annual newly-increased 1,000,000 People.Percutaneous coronary intervention (pci) (percutaneous coronary intervention, PCI), also referred to as percutaneous hat Shape artery angioplasty (PTCA), have become the Main Means of coronary heart disease treatment.Percutaneous coronary intervention (pci) refers to Using Femoral Approaches or Transradial Artery, guiding catheter delivered to coronary ostium to be expanded, then by correspondingly sized ball Capsule is sent to narrow section along guide wire or other related equipments, is carried out according to the characteristics of lesion with appropriate pressure and time Expansion, reach and release coronary artery stenosis or obstruction, rebuild the technology of coronary flow.In percutaneous coronary angiopoiesis In art, right femoral artery, vein are punctured using Seldinger puncture methods first, and insert sheath, guiding tube is sent to coronary artery Mouthful, seal wire and sacculus are sent at the guiding mouth of pipe, are then sent into seal wire in coronary artery under fluoroscopy, with seal wire knob control Seal wire processed, it is passed to narrow until blood vessel distal end is sent into, after seal wire position is fixed, you can be sent into sacculus along seal wire direction, directly Sacculus to dilating catheter is positioned at lesion locations.After positioning, by one or many air bag expansions, sacculus reaches predetermined expansion Size, so as to open vascular lesion narrow positions, in order to which sacculus is positioned at into narrowed areas, foley's tube needs to have suitably Pushability (transmitting the ability of power along the length of conduit), trackability and flexibility.Conventional foley's tube usually has relative Harder nearside axle portion (in order to which conduit is in endoceliac traveling) and relatively flexible distal shaft portion be not (in order to to blood Tube wall is caused in the case of operating by blood vessel inside complications.

Chinese patent literature CN103796707B discloses a kind of conduit that thin hypotube is cut with ladder, and conduit has Hypotube, hypotube have the tabs limited by the first oblique cutting part, supporting section and the second angled cut.Middle shaft component bag The expansion chamber being in fluid communication with the expansion chamber of hypotube and guidewire lumen are included, the expansion chamber of middle shaft component is configured to receive hypotube At least partially.Therefrom shaft component is distally extending for distal tubular shaft component.Distal tubular axle structure is therein with being limited to The guidewire lumen of guidewire lumen and expansion chamber, the guidewire lumen of distal tubular shaft component and middle shaft component is in fluid communication.Distal tubular member The expansion chamber of expansion chamber and middle shaft component be in fluid communication, sacculus is connected to distal tubular shaft component and connected with expansion chamber fluid It is logical.

In the above prior art, for flexibility and/or rigidity with change, foley's tube include outer tubular member and Middle shaft component, the hypotube are divided into distal portions and proximal part, and the expansion chamber of its distal portions from middle shaft component stretches to The distal portion of middle shaft component, the distal end of the hypotube have the first cutting part, supporting section, the laminated structure of the second cutting part. The proximal part of hypotube is harder, has more in endoceliac traveling, the middle shaft component coupled with hypotube for conduit Flexibility, the outer tubular member being connected with middle shaft component are more flexible material.That is, the foley's tube of prior art is deposited In multiple changeover portions：The inner surface of the distal portion of the outer surface of distal tubular member and middle shaft component joins, make middle shaft component with Distal tubular member connects；Meanwhile the outer surface of hypotube is combined with axis inner surface of component；In addition, the first of hypotube cuts The portion of cutting extends distally beyond middle shaft component and enters distal tubular member.Prior art by distal tubular member, hypotube, in Shaft component is formed, and each assembly material is different from rigidity, and especially coincidence part is stronger compared to the rigidity of non-coincidence part, causes above-mentioned mistake Crossing section causes rigidity and/or flexibility not to be uniformly distributed.Therefore, in sacculus dilating catheter in blood vessel traveling process, the mistake Cross section coincidence part can not rounding off, may will will along its length produce kinking, it will cause foley's tube suitable Profit reaches lesion locations.

In addition, the sacculus dilating catheter of prior art, hypotube needs multiple techniques with middle shaft component, distal tubular member Step is welded, and technique is cumbersome, it is understood that there may be the risk of leakage, causes the efficiency of transmission of sacculus dilating catheter to decline.

The content of the invention

Therefore, the technical problem to be solved in the present invention is to overcome foley's tube rigidity and/or flexibility of the prior art Can not rounding off, cause distal component to occur kinking, the defects of causing foley's tube can not smoothly reach lesion locations, and then There is provided it is a kind of with can be with the hypotube of rounding off and the sacculus dilating catheter with the hypotube with distal component.

In order to solve the above-mentioned technical problem, a kind of hypotube of the invention, from near-end to distally forming successively：Pipe Section, its cross section are the tubular structure of annulus；Flat tube section, its cross section are the tubular structure of crescent；Supporting section, the support Section is to extend along the circular arc sheet structure that direction is gradually reduced along the extension of proximate direction and its cross sectional dimensions.

Changeover portion is provided between the flat tube section and the supporting section.

The changeover portion cuts to be formed for the distal radial of the flat tube section.

The supporting section is the distal end axially oblique cutting formation of the flat tube section.

The supporting section axial length is 30mm.

Each section of described hypotube forms by phase same material.

A kind of sacculus dilating catheter, including：Sacculus, the balloon interior are provided with cavity；Distal tube, its distal end and the ball Capsule fixes connection；The sacculus dilating catheter also includes hypotube, and the supporting section of the hypotube and the part flat tube section are stretched Enter in the distal tube, the near-end of the distal tube has the fit structure being adapted with the crescent side wall of the flat tube section.

The sacculus dilating catheter also includes lumen tube, and the lumen tube runs through the sacculus and the distal tube.

The flat tube section of the lumen tube and hypotube radially offsets and fixed in the proximal end of the distal tube.

The sacculus dilating catheter also includes development pipe, and the development pipe is arranged in the cavity of sacculus, and is arranged at institute State in lumen tube.

Technical solution of the present invention, have the following advantages that：

1. in hypotube of the present invention, from near-end to distally forming successively：Pipe section, its cross section are annulus Tubular structure；Flat tube section, its cross section are the tubular structure of crescent；Supporting section, the supporting section are along proximate Direction extends and its cross sectional dimensions extends along the circular arc sheet structure that direction is gradually reduced.The flat tube section is that cross section is The tubular structure of crescent, the crescent tubular structure make the even transition of pipe section and flat tube section, the hypotube flat tube Section can make in the traveling process of sacculus dilating catheter, and distal component is stably promoted.The supporting section is along proximate Direction extends and its cross sectional dimensions extends along the circular arc sheet structure that direction is gradually reduced, so as to ensure hypotube in sacculus Dilating catheter distal end can more rounding off, in order to foley's tube in the blood vessel have preferably push performance, it is desirable to pipe section With more higher intensity, pipe end distal end is handled the part before forming flat tube section, makes flat tube section strong after being molded Degree is more relatively low than pipe section, and sacculus dilating catheter is promoted along guiding wire toward diseased region in use, lesion Nearby blood vessels caliber is smaller and structure is increasingly complex for position, therefore it is required that sacculus dilating catheter distal portions need it is very high flexible Property.After flat tube section bonds with the assembling of foley's tube distal portions, two-part strength difference can be bigger, therefore at flat section of pipe end End adds the circular arc sheet structure of gradual change, and two parts strength difference is eliminated with this.It is pipe section that the hypotube has, flat Pipeline section, supporting section cross sectional dimensions gradually decrease, and good supporting role and rounding off effect are played jointly, so as to avoid The structure of multistage different-stiffness or material produces the possibility of kinking along its length in hypotube distal end.

2. in hypotube of the present invention, changeover portion is provided between the flat tube section and the supporting section, it is described Changeover portion forms for the distal radial cutting of the flat tube section.The changeover portion coordinates with lumen tube kink, ensure that sacculus Conduit rounding off.

3. in hypotube of the present invention, each section of the hypotube by phase same material composition, with existing skill Art is that all structures are formed by same material compared to the advantage of the design, eliminates the difference of mutual intensity Property, therefore mechanics gradual change is more smooth.

4. in hypotube of the present invention, pipe section and part flat tube section outer surface scribble the hydrophilic of 6-14 μm of PTFE Coating, the PTFE hydrophilic coatings can make the exposed hypotube outside distal tube have stronger passing through property in the blood vessel.

5. in sacculus dilating catheter of the present invention, including：Sacculus, the balloon interior are provided with cavity；Distal tube, Its distal end is fixed with the sacculus and connected；Also include hypotube, the supporting section of the hypotube and the part flat tube section stretch into In the distal tube, the near-end of the distal tube has the fit structure being adapted with the crescent side wall of the flat tube section, because This, the supporting section of the hypotube is directly protruding into distal tube with part flat tube section, the two sides of the supporting section respectively with far The inner surface of side pipe and the outer surface of lumen tube fit, and then ensure rounding off；The changeover portion and lumen tube it is curved Folding part coordinates, and the kink of the lumen tube can reduce supporting section and variation in rigidity caused by the structure difference of flat tube section, from And ensure the rounding off of distal component；The part flat tube section for extending into distal tube, its outer surface side are matched somebody with somebody with distal tube Close, the outer surface of opposite side and lumen tube coordinates, so as to ensure rounding off.

6. in sacculus dilating catheter of the present invention, the flat tube section of the lumen tube and hypotube is in the distal tube Proximal end radially offset and fixed, the flat tube section of the near-end of the distal tube and the near-end of lumen tube respectively with hypotube is carried out Thermal weld, it is that a technique walks that two Process step combinations are welded in guide wire exit openings welding and distal component by original manufacturing process Suddenly, technological process has been saved, while has reduced the risk of leakage, ensure that the efficiency of transmission of sacculus dilating catheter.

7. in sacculus dilating catheter of the present invention, the development pipe is arranged in the cavity of sacculus, and is arranged at In the lumen tube.The development pipe is made up of developing material, is easy to observe overall picture at coronary artery pathological changes, while measure lesion Length, so as to reduce the difficulty of operation and risk.

Brief description of the drawings

, below will be to specific in order to illustrate more clearly of the specific embodiment of the invention or technical scheme of the prior art The required accompanying drawing used is briefly described in embodiment or description of the prior art, it should be apparent that, in describing below Accompanying drawing is some embodiments of the present invention, for those of ordinary skill in the art, before creative work is not paid Put, other accompanying drawings can also be obtained according to these accompanying drawings.

Fig. 1 is the structural representation of the sacculus dilating catheter provided in the first embodiment of the present invention；

Fig. 2 is the structural representation of the hypotube shown in Fig. 1；

Fig. 3 is the longitudinal profile schematic diagram of hypotube flat tube portion shown in Fig. 2；

Description of reference numerals：

1- tip tubes；2- sacculus；3- development pipes；4- distal tubes；5- lumen tubes；6- hypotubes；

61- pipe sections；62- flat tube sections；63- changeover portions；64- supporting sections.

Embodiment

Technical scheme is clearly and completely described below in conjunction with accompanying drawing, it is clear that described implementation Example is part of the embodiment of the present invention, rather than whole embodiments.Based on the embodiment in the present invention, ordinary skill The every other embodiment that personnel are obtained under the premise of creative work is not made, belongs to the scope of protection of the invention.

In the description of the invention, it is necessary to which explanation, unless otherwise clearly defined and limited, " near-end " refers in term During sacculus dilating catheter use, close to nearlyer one end of operator；" distal end " is that sacculus dilating catheter used in term Cheng Zhong, one end away from operator.

As long as in addition, technical characteristic involved in invention described below different embodiments non-structure each other It is be combined with each other into conflict can.

Embodiment 1

Fig. 1 show the sacculus dilating catheter described in the present embodiment, and it includes sacculus 2, and the inside of sacculus 2 is provided with sky Chamber；Distal tube 4, its distal end are fixed with the sacculus 2 and connected；Tip tube 1, the tip tube 1 is relative to the distal tube 4 in institute The setting of the sacculus other end is stated, the tip tube 1 is connected with the distal end of the sacculus 2；Lumen tube 5, the lumen tube 5 is through described Sacculus 2 and the distal tube 4, the hypotube 6 include pipe section 61, flat tube section 62, changeover portion 63 and support end 64, the branch A part for support end 64 and flat tube section 62 is extend into distal tube 4, the hypotube 6 stretched into inside distal tube and lumen tube 5 Outside coordinates, and the flat tube section 62 of the hypotube 6 radially offsets and fixed in the proximal end of the distal tube 4 with lumen tube 5；Institute Development pipe 3 is stated, development pipe 3 is arranged in the cavity of sacculus 2, and is arranged in the lumen tube 5.

Tip tube 1 described in the present embodiment, is made of nylon elastic material, including polyether block amide (Pebax) Copolymer, in the present embodiment, tip tube 1 are made up of Pebax5533 materials.Make tip tube 1 that there is good resilience.

Development pipe 3 described in the present embodiment.It is described development the ring of pipe 3 forge in lumen tube 5, be easy to observe coronary artery disease Overall picture at change, while length of lesion is measured, so as to reduce the difficulty of operation and risk.

Distal tube 4 described in the present embodiment, is made of nylon 11 material.By using made of more flexible material Distal tube ensures that the transition of hypotube and distal component is rounder and more smooth.

Lumen tube 5 described in the present embodiment is three-decker, wherein, outer layer uses nylon material, and intermediate layer is using tree Fat material, maleic anhydride grafts (orevac) material is used in the present embodiment, aids in the bonding of inner layer material and cladding material, With higher rheological property and multilayer processing performance；Internal layer is made of polyethylene (PE) material.Made of the PE materials The internal layer of lumen tube, soft durometer are moderate.The three-decker of the lumen tube 5, it provides moderate rigidity and/or flexibility, so as to Ensure the rounding off of distal component.

Hypotube 6 described in the present embodiment, from near-end to distally forming successively：Pipe section 61, its cross section are circle The tubular structure of ring；Flat tube section 62, its cross section are the tubular structure of crescent, as shown in Figure 3；Supporting section 64, the support Section 64 is to extend along the circular arc sheet structure that direction is gradually reduced along the extension of proximate direction and its cross sectional dimensions, such as Shown in Fig. 2.The supporting section 64 is the distal end axially oblique cutting formation of the flat tube section 62.The crescent tubular structure makes The even transition of pipe section 61 and flat tube section 62, meanwhile, the flat tube section 62 of the hypotube 6 can make the row of sacculus dilating catheter During entering, ensure corresponding rigidity, distal component is stably promoted.The supporting section 64 is to prolong along proximate direction Stretch and its cross sectional dimensions extends along the circular arc sheet structure that direction is gradually reduced, so as to ensure that hypotube is led in balloon expandable Pipe distal end can more rounding off.

Changeover portion 63 is provided between the flat tube section 62 and the supporting section 64 of the hypotube 6, the changeover portion 63 is The distal radial of the flat tube section 62 cuts to be formed.The supporting section 64 of the hypotube 6 and the part flat tube section 62 stretch into institute To state in distal tube 4, the near-end of the distal tube 4 has the structure being adapted with the crescent side wall of the flat tube section 62, therefore, The supporting section 64 of the hypotube is directly protruding into distal tube 4 with part flat tube section 62, the two sides difference of the supporting section 64 Fitted with the inner surface of distal tube 4 and the outer surface of lumen tube 5, and then ensure rounding off；The changeover portion 63 with it is interior The kink of lumen 5 coordinates, and the kink of the lumen tube 5 can reduce supporting section 64 and the structure difference of flat tube section 62 causes Variation in rigidity, so as to ensure the rounding off of distal component；The part flat tube section 62 for extending into distal tube, its outer surface Side coordinates with distal tube 4, and opposite side and the outer surface of lumen tube 5 coordinate, so as to ensure rounding off.

The material of the hypotube is the higher material of hardness, it is preferable that the material of the hypotube is 304 stainless steels Material, ensure to provide rigidity in hypotube traveling process.Preferably, the axial length of the supporting section 64 of the hypotube 6 is 30mm, So as to ensure that the distal end of the hypotube 6 can provide a supporting role.

The part not extended into the hypotube 6 in distal tube 4, i.e., the pipe section 61 of described hypotube 6 and part are flat Pipeline section 62,6-14 μm of polytetrafluoroethylene (PTFE) (Poly tetra fluoro ethylene, PTFE) material is scribbled in its outer surface Hydrophilic coating.The PTFE hydrophilic coatings can make the exposed hypotube outside distal tube have stronger pass through in the blood vessel Property.

Sacculus dilating catheter described in the present embodiment, as shown in figure 1, its installation process is：First, by the near-end of sacculus 2 Welded with the distal end of distal tube 4；The distal end of the distally pipe 4 of lumen tube 5 is extend into sacculus 2, and worn from the distal end of sacculus 2 Go out；The part that the lumen tube 5 passes sacculus 2 is put into tip tube 1 again, the distal end of the near-end of tip tube 1 and sacculus 2 is welded Connect；Then, hypotube 6 is inserted into the cavity that distal tube 4 surrounds with lumen tube 3；Finally by the flat tube section 62 of hypotube 6, The near-end and the near-end of lumen tube 5 of distal tube 4 are welded in distal tube near-end, are so far completed.

In above-described embodiment, the weld length of the sacculus 2 and the tip tube 1 is 4-5mm.The hypotube 6, inner chamber The weld length of pipe 5 and distal tube 4 is 20mm.It should be noted that above-mentioned concrete numerical value is only for ease of those skilled in the art The specific example for understanding the scheme of the present embodiment and lifting, above-mentioned concrete numerical value are understood not to the present embodiment technical scheme The limitation of composition.

Welding method described in above-described embodiment is to be enclosed on silicone tube to need soldering part overlapping part, is placed after drying Welded on welding equipment, after ensureing that firm welding combines, remove silica gel sheath.

Above-mentioned welding method uses hot weld connection technology, and using thermal weld compared to for laser welding, its speed of welding is obvious Improve, so as to improve operating efficiency.

Embodiment 2

On the basis of above-mentioned implementation, state each section of the hypotube 6 forms the present embodiment by phase same material.This implementation In example, state each section of the hypotube 6 uses stainless steel 304 material.The hypotube 6 formed using same material, The otherness of each section of mutual intensity is eliminated, therefore mechanics gradual change is more smooth.Can certainly be of the prior art Other materials, it is only necessary to which each section is phase same material.

Obviously, above-described embodiment is only intended to clearly illustrate example, and is not the restriction to embodiment.It is right For those of ordinary skill in the art, can also make on the basis of the above description it is other it is various forms of change or Change.There is no necessity and possibility to exhaust all the enbodiments.And the obvious change thus extended out or Among changing still in the protection domain of the invention.